Antiseptic preparation of patient's skin for surgery conventionally includes a 3-10 minute scrubbing of the affected area with an antiseptic soap solution followed by the application of a water-soluble antiseptic paint solution.
These solutions are generally applied with saturated sponges that are attached to a blade or held with forceps. These sponges are often saturated by soaking them in open pans of solution. Sometimes, sponges with attached handles are provided in a plastic or aluminum foil laminate pouch containing enough liquid to saturate the sponges. In some products the sponges are supplied dry in a sterile “kit” with the antiseptic solutions provided in relatively thin walled 4 oz. polyethylene bottles. These bottles generally have wall thickness less than about 500 microns.
While inexpensive, these techniques are messy and offer little control over inadvertent dripping of the solution into areas where it is undesired. Since many of the available solutions contain active ingredients such as alcohol and iodine which can be irritating if allowed to pool in areas and left in contact with the skin, good control over the application has long been desirable.
Over the years, devices have been developed in an attempt to prevent solution dripping associated with these techniques, and to reduce the time required for application of the antiseptic solution. In particular, the DURAPREP products commercially available from 3M Company (St. Paul, Minn.) have enjoyed commercial success by providing substantially drip-free, convenient application of antiseptic solutions.
Coassigned U.S. Pat. No. 4,925,327 describes a liquid applicator that incorporates a rigid, porous metering insert to regulate the flow rate of liquid between the applicator handle and a foam sponge covering a major orifice of the handle. The liquid to be dispensed is contained in a rupturable reservoir removably affixed at the other major orifice of the handle.
Coassigned U.S. Pat. No. 5,658,084 further discloses a liquid applicator where the liquid is contained in a frangible ampoule inside the body of the applicator. This ampoule is supported and protected by a deformable element that prevents unintentional breakage of the ampoule from impact during storage and handling before use. The applicator is actuated by pushing at least a portion of the frangible ampoule through an aperture in the deformable element and into contact with a means for breaking the ampoule.
One consideration in the design of these delivery devices is to prevent contact between the clinician and the skin of the patient to avoid contamination. This may be accomplished by providing a handle that is preferably at least four inches long and oriented at an angle of 30-90 degrees to the head of the sponge. While this is convenient for application to skin, it is completely unsuitable for applying an antiseptic solution into, e.g., the vaginal canal. In contrast, typical sponge sticks available in kits have the sponge and handle in the same plane. While this is suitable for prepping the vaginal canal, it is difficult to use on skin because of a high potential for contact between the clinician's hand and the patient.
U.S. Pat. No. 4,507,111 illustrates still another surgical scrub dispensing system. In this invention the antiseptic prep solution is housed in a separate elongated cartridge adapted to be longitudinally slidable in an elongated hollow handle member. The handle member has attached thereto an absorbent sponge. The handle member further includes two hollow spikes formed on the inside of said member which provide flow communication from the interior of the hollow handle member to the absorbent sponge. When the spikes puncture the elongated handle one of the spikes serves to vent the container and one of the spikes serves to deliver the fluid. Since both spikes reside on one end of the container they must be spaced and the handle held at a precise angle to ensure a fluid head difference necessary for proper venting. Many clinicians have been trained to hold the applicators in a vertical orientation when activating. This applicator would not, however, properly vent when held vertically.
Typical antiseptic composition applicators are provided with sterile exterior surfaces to avoid contaminating the patient with microorganisms that could be located on the exterior surfaces of the applicators. Many of these applicators are sterilized by exposure to ethylene oxide gas. Surprisingly, we have found that kits containing iodophor-based antiseptic compositions in polyethylene bottles having wall thicknesses of less than about 500 microns contain significant levels of iodohydrin (2-iodoethanol). Iodohydrin is considered quite toxic and is believed to be formed by reaction of ethylene oxide which has penetrated through the container with hydrogen iodide found in the antiseptic composition. Ethylene oxide itself is also quite toxic and its by product levels in medical devices are tightly controlled by the Food and Drug Administration. Similar problems may result from sterilization by others gases such as hydrogen peroxide plasma and the like. Therefore, even in non-iodophor containing antiseptic compositions, it is highly desirable to prevent ethylene oxide and other chemical sterilants from diffusing into the container during sterilization.
U.S. Pat. No. 4,799,815 describes a liquid dispensing swab applicator system in which a hermetically sealed fluid filled tube having an absorbent swab at one end is opened by puncturing the tube with an external jig. The fluid flows out over the exterior surface of the tube and into the swab. This delivery method may not, however, be practical for larger fluid volumes of low viscosity fluids that need to be delivered rapidly (such as presurgical fluids) because the fluid exits at a rate much faster than the absorbent could absorb the fluid resulting in excessive dripping and mess.
While these products have provided a considerable advance, they are complex to manufacture, placing them beyond the means of some health care consumers.